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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 095 09 15 000
Date submitted: 9/21/2015
Manufacturer:Baxter Healthcare
Device Type:EXACTAMIX compounder
Description:Intravenous Solution Compounders
Medical Device Identifier:Model numbers 2400-DY and 2400-DX
Reason of Field Safety Corrective Action:Baxter Healthcare Corporation is providing you with this important information regarding the application software for EXACTAMIX compounders’ model numbers 2400-DY and 2400-DX.
Remedy Action:Baxter is now providing their customers with a revised Operator’s Manual incorporating this important information.
Athorized Representative/Importer/Distributor:Baxter AG
Report Source:NCMDR
Source Ref. Number:E77341F0342BF
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Baxter.pdf